Comparison of Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty: a Prospective, Double-blinded, Noninferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years of age or older
- •Undergoing total shoulder arthroplasty
- •Willing and able to sign consent form to participate in study
排除标准
- •< 18 years of age
- •Unwilling or unable to sign consent form to participate in study
- •Allergy to local anesthetic
- •Medical contraindication to interscalene nerve block
- •Chronic opioid use
研究组 & 干预措施
Liposomal Bupivacaine
Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.
干预措施: Liposomal bupivacaine (Drug)
Liposomal Bupivacaine
Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.
干预措施: Bupivacaine (Drug)
Non-liposomal Bupivacaine
Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Opioid Consumption
时间窗: 72 hours postoperative
Morphine equivalents used during first 72 hours after surgery
次要结局
- Numeric Rating Scale Reported Pain Scores(72 hours postoperative)
- Nerve Block Related Adverse Events(72 hours postoperative)
- Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale(72 hours postoperative)
- Patients with Additional, Unanticipated Pain Related Medical Encounters(72 hours postoperative)
研究者
D. Aric Elmer, MD
Principal Investigator
University of Virginia